Watery EyesNCT05683613
Watering of the Eyes Following Uneventful Phacoemulsification Cataract Surgery
An observational study of Watery Eyes, run by Sohag University.
Trial summary
An observational study aiming to assess the incidence and possible causes of post phacoemulsification watery eye. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Watery Eyes
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50_ 80 year old Patients with age related cataract with no watery eyes subjected for phacoemulsification cataract surgery
Who may be able to join
- patients with age related cataract.
Who cannot join
- patients with watering of the eyes or ocular surface disease.
- patients with previous ocular surgeries .
- patients with glaucoma, uveitis, cornealor retinal pathologies.
About this study
An observational study aiming to assess the incidence and possible causes of post phacoemulsification watery eye.
Read the detailed description
This study will be conducted on patients who will undergo cataract extraction at Sohag university hospitals to evaluate the incidence of watery eyes in patients after phacoemulsification by one week , one month and three month.
- Study Design: observational study.
- Inclusion Criteria:
Patients with age-related cataract.
- Exclusion Criteria:
- patients with watering of eyes or ocular surface diseases or watering of the eyes .
- patients with previous ocular surgeries.
- patients with glaucoma, uveitis, corneal or retinal pathologies.
- Preoperative Evaluation:
Each patient will be subjected to the following:
Detailed history taking and full ophthalmological examination. Fluorescein dye disappearance test. Syringing and probing. Schirmer's test. Tear break up time test. Measurement of punctal diameter by AS-OCT.
- Operative procedures:
- regional anesthesia.
- phaco technique : stop and shop.
- cumulative dissipated energy (CDE ) \&fluid flow.
- Follow-up regimen: will be as follows:
- patients will be examined after surgery on: 1st postoperative week, 1st month, 3rd month.
- The following will be recorded for each patient:
- symptoms of watery eyes, visual acuity, IOP, slit lamp examination.
- dye disappearance test.
- Schirmer's test.
- tear break up time test.
- anterior segment OCT.
- Conditions
- Watery Eyes
- Medical subject headings
- Lacerations
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the incidence and possible causes of post phacoemulsification watery eye.
Patients are examined preoperatively and postoperatively by flourescein disappearance test, probing and syringing, schirmer's test,tear breakup time test and anterior segment optical coherence tomography to detect incidence and causes of post phacoemulsification watery eye.
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Watery EyesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Helmy Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683613
- Sponsor's protocol ID
- AHMahmoud
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watering of the Eyes Following Uneventful Phacoemulsification Cataract Surgery
- ClinicalTrials.gov ID
- NCT05683613
- Acronym / sponsor ID
- AHMahmoud
- Conditions
- Watery Eyes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study aiming to assess the incidence and possible causes of post phacoemulsification watery eye.
Detailed description
This study will be conducted on patients who will undergo cataract extraction at Sohag university hospitals to evaluate the incidence of watery eyes in patients after phacoemulsification by one week , one month and three month.
- Study Design: observational study.
- Inclusion Criteria:
Patients with age-related cataract.
- Exclusion Criteria:
- patients with watering of eyes or ocular surface diseases or watering of the eyes .
- patients with previous ocular surgeries.
- patients with glaucoma, uveitis, corneal or retinal pathologies.
- Preoperative Evaluation:
Each patient will be subjected to the following:
Detailed history taking and full ophthalmological examination. Fluorescein dye disappearance test. Syringing and probing. Schirmer's test. Tear break up time test. Measurement of punctal diameter by AS-OCT.
- Operative procedures:
- regional anesthesia.
- phaco technique : stop and shop.
- cumulative dissipated energy (CDE ) \&fluid flow.
- Follow-up regimen: will be as follows:
- patients will be examined after surgery on: 1st postoperative week, 1st month, 3rd month.
- The following will be recorded for each patient:
- symptoms of watery eyes, visual acuity, IOP, slit lamp examination.
- dye disappearance test.
- Schirmer's test.
- tear break up time test.
- anterior segment OCT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50_ 80 year old Patients with age related cataract with no watery eyes subjected for phacoemulsification cataract surgery
Key inclusion criteria (1 listed)
- patients with age related cataract.
Key exclusion criteria (3 listed)
- patients with watering of the eyes or ocular surface disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the incidence and possible causes of post phacoemulsification watery eye.
Time frame: Five months
Patients are examined preoperatively and postoperatively by flourescein disappearance test, probing and syringing, schirmer's test,tear breakup time test and anterior segment optical coherence tomography to detect incidence and causes of post phacoemulsification watery eye.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Watery Eyes, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the incidence and possible causes of post phacoemulsification watery eye. (time frame: Five months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.